|ATC code||A10BX12 (WHO)|
|Chemical and physical data|
|Molar mass||450.91 g/mol|
|3D model (Jmol)||Interactive image|
Empagliflozin (trade name Jardiance) is a drug of the gliflozin class, approved for the treatment of type 2 diabetes in adults in 2014. It was developed by Boehringer Ingelheim and Eli Lilly and Company.
When taken in dosages of 10 or 25 mg once a day, the incidence of adverse events was similar to placebo. However, there was a higher frequency of urinary tract infections.
There are concerns it may increase the risk of diabetic ketoacidosis.
In August 2015, release of the post-marketing clinical trial EMPA-REG OUTCOME addressed the addition of empagliflozin to the standard of care for preventing myocardial infarction, stroke, and cardiovascular death. Empaglifozin was the first and, to date, only oral type-2 diabetes medicine shown to reduce the risk of cardiovascular death in a clinical trial.
Mode of action
Empagliflozin is an inhibitor of the sodium glucose co-transporter-2 (SGLT-2), which is found almost exclusively in the proximal tubules of nephronic components in the kidneys. SGLT-2 accounts for about 90 percent of glucose reabsorption into the blood. Blocking SGLT-2 reduces blood glucose by blocking glucose reabsorption in the kidney and thereby excreting glucose (i.e., blood sugar) via the urine.
As of May 2013, Boehringer and Lilly had submitted applications for marketing approval to the European Medicines Agency and the U.S. Food and Drug Administration (FDA). The drug was approved in Europe in May 2014 and was approved by the FDA in August 2014. The FDA required four postmarketing studies: a cardiovascular outcomes trial, and two studies in children, and a toxicity study in animals related to the pediatric trials.
- Empagliflozin/linagliptin (Glyxambi)
- Grempler R, Thomas L, Eckhardt M, Himmelsbach F, Sauer A, Sharp DE, Bakker RA, Mark M, Klein T, Eickelmann P (January 2012). "Empagliflozin, a novel selective sodium glucose cotransporter-2 (SGLT-2) inhibitor: characterisation and comparison with other SGLT-2 inhibitors". Diabetes Obes Metab. 14 (1): 83–90. doi:10.1111/j.1463-1326.2011.01517.x. PMID 21985634.
- Miriam E. Tucker for Medscape Medical News. May 07, 2013 First Details of Empagliflozin Trials Follow US and EU Filings
- NICE. Type 2 diabetes: empagliflozin
- FDA (2015-05-15). "SGLT2 inhibitors: Drug Safety Communication - FDA Warns Medicines May Result in a Serious Condition of Too Much Acid in the Blood". Retrieved 19 May 2015.
- Zinman, Bernard; Wanner, Christoph; Lachin, John M.; Fitchett, David; Bluhmki, Erich; Hantel, Stefan; Mattheus, Michaela; Devins, Theresa; Johansen, Odd Erik (2015-11-25). "Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes". New England Journal of Medicine. 373 (22): 2117–2128. doi:10.1056/nejmoa1504720.
- Staton, T. (20 August 2015). "In a first for diabetes, Lilly and Boehringer's Jardiance prevents heart attacks, strokes in trial". FierceMarkets/Questex. Retrieved 20 August 2015.
- "FDA Advisory Committee recommends approval of Jardiance® (empagliflozin) for cardiovascular indication in 12-11 vote". Yahoo! Finance. 28 June 2016. Retrieved 10 August 2016.
- Abdul-Ghani MA, DeFronzo RA (September 2008). "Inhibition of renal glucose reabsorption: a novel strategy for achieving glucose control in type 2 diabetes mellitus". Endocr Pract. 14 (6): 782–90. doi:10.4158/ep.14.6.782. PMID 18996802.
- Nair S, Wilding JP (January 2010). "Sodium glucose cotransporter 2 inhibitors as a new treatment for diabetes mellitus". J. Clin. Endocrinol. Metab. 95 (1): 34–42. doi:10.1210/jc.2009-0473. PMID 19892839.
- Bays H (March 2009). "From victim to ally: the kidney as an emerging target for the treatment of diabetes mellitus". Curr Med Res Opin. 25 (3): 671–81. doi:10.1185/03007990802710422. PMID 19232040.
- Elizabeth Mechatie for Clinical Endocrinology News Digital Network August 1, 2014 FDA approves empagliflozin for adults with type 2 diabetes